ReconsiderationQuestionnaireAdult

Attach 19. Reconsideration Questionnaire Adult.docx

Continuation of National Children's Study Vanguard (Pilot) Study Data Collection: Study Visits through 60-Months

ReconsiderationQuestionnaireAdult

OMB: 0925-0593

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OMB #: 0925-0593

OMB Expiration Date: 06/30/2017

Reconsideration Questionnaire - Adult, Phase 2g

OMB Specification




Reconsideration Questionnaire - Adult


Event Category:

Trigger-Based, Pre-Preg, PV2; Time-Based,12M, 24M, 36M, 48M, 60M

Event:

Pre-Preg, PV2, 12M, 24M, 36M, 48M, 60M

Administration:

N/A

Instrument Target:

Pre-Pregnant Woman (Pre-Preg);
Pregnant Woman (PV2);
Primary Caregiver (12M, 24M, 36M, 48M, 60M)

Instrument Respondent:

Pre-Pregnant Woman (Pre-Preg);
Pregnant Woman (PV2);
Primary Caregiver (12M, 24M, 36M, 48M, 60M)

Domain:

Consent

Document Category:

Questionnaire

Method:

Data Collector Administered

Mode (for this instrument*):

In-Person, CAI;
Phone, CAI

OMB Approved Modes:

In-Person, CAI;
Phone, CAI

Estimated Administration Time:

1 minute

Multiple Child/Sibling Consideration:

Per Event

Special Considerations:

N/A

Version:

1.0

MDES Release:

4.1


*This instrument is OMB-approved for multi-mode administration but this version of the instrument is designed for administration in this/these mode(s) only.


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Reconsideration Questionnaire - Adult



TABLE OF CONTENTS





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Reconsideration Questionnaire - Adult


GENERAL PROGRAMMER INSTRUCTIONS:

WHEN PROGRAMMING INSTRUMENTS, VALIDATE FIELD LENGTHS AND TYPES AGAINST THE MDES TO ENSURE DATA COLLECTION RESPONSES DO NOT EXCEED THOSE OF THE MDES. SOME GENERAL ITEM LIMITS USED ARE AS FOLLOWS:

DATA ELEMENT FIELDS

MAXIMUM CHARACTERS PERMITTED

DATA TYPE

PROGRAMMER INSTRUCTIONS

ADDRESS AND EMAIL FIELDS

100

CHARACTER


UNIT AND PHONE FIELDS

10

CHARACTER


_OTH AND COMMENT FIELDS

255

CHARACTER

  • Limit text to 255 characters

FIRST NAME AND LAST NAME

30

CHARACTER

  • Limit text to 30 characters

ALL ID FIELDS

36

CHARACTER


ZIP CODE

5

CHARACTER


ZIP CODE LAST FOUR

4

CHARACTER


CITY

50

CHARACTER


DOB AND ALL OTHER DATE FIELDS (E.G., DT, DATE, ETC.)

10




CHARACTER



  • DISPLAY AS MM/DD/YYYY

  • STORE AS YYYY-MM-DD

  • HARD EDITS:

MM MUST EQUAL 01 TO 12

DD MUST EQUAL 01 TO 31

YYYY MUST BE BETWEEN 1900 AND CURRENT YEAR.

TIME VARIABLES

TWO-DIGIT HOUR AND TWO-DIGIT MINUTE, AM/PM DESIGNATION

NUMERIC

  • HARD EDITS:

HOURS MUST BE BETWEEN 00 AND 12;

MINUTES MUST BE BETWEEN 00 AND 59

NUMBER OF HOURS PER DAY

TWO-DIGIT HOUR

NUMERIC

  • HARD EDITS:

HOURS MUST BE BETWEEN 0 AND 24

NUMBER OF DAYS PER WEEK

ONE-DIGIT

NUMERIC

  • HARD EDITS:

DAYS PER WEEK MUST BE BETWEEN 1 AND 7



Guidelines for Instrument Target and Respondent :

IN MDES 4.0, THE INSTRUMENTS HAVE BEEN DIVIDED BASED ON INSTRUMENT TARGET AND INSTRUMENT RESPONDENT. THE INSTRUMENT TARGET AND INSTRUMENT RESPONDENT ARE PART OF THE STANDARD INSTRUMENT HEADER INFORMATION ON ALL INSTRUMENTS, AND ADDITIONAL TARGETS HAVE BEEN DEFINED, INCLUDING THE CHILD’S PRIMARY OR SECONDARY ADDRESS. REFER TO THE DATA DICTIONARY FOR A COMPLETE LIST OF ALL INSTRUMENT TARGETS AND RESPONDENTS.






PRELOADS


Preload Variable Name

Table Name

Preload Comment

Release Version

Table Type

EVENT_TYPE

EVENT


V3.5

Operational

FIRST_NAME

PERSON

FOR NCS CHILD

V3.5

Operational

PERSON_PID_ID

LINK_PERSON_PARTICIPANT

FOR NCS CHILD

V3.5

Operational

SAMPLE_CONSENT_GIVEN

PARTICIPANT_CONSENT_SAMPLE


V3.5

Operational

SAMPLE_CONSENT_TYPE

PARTICIPANT_CONSENT_SAMPLE


V3.5

Operational



RECONSIDERATION QUESTIONNAIRE - ADULT


(TIME_STAMP_RQA_ST).


PROGRAMMER INSTRUCTIONS

  • INSERT DATE/TIME STAMP.

  • PRELOAD INS_TARGET_PID FOR PARTICIPANT AND INS_RESPONDENT_PID FOR RESPONDENT. 

  • IF EVENT_TYPE = 27 (12-MONTH), 37 (36-MONTH), 40 (48-MONTH), OR 41 (60-MONTH) AND IF FIRST_NAME ≠ -1 OR -2, DISPLAY CHILD'S FIRST NAME IN C_FNAME AS APPROPRIATE THROUGHOUT INSTRUMENT.


RQA01000/(RECON_INTRO). As part of the research activities for today’s visit, we would like to collect some samples from you.   You can always say no, but we would like to offer you the opportunity to provide samples to help us reach the goals of the Study.


DATA COLLECTOR INSTRUCTIONS

  • DURING THE LAST INFORMED CONSENT, THE PRE-PREGNANT WOMAN/PREGNANT WOMAN/ADULT CAREGIVER EITHER

    • CONSENTED TO PROVIDE BIOLOGICAL SAMPLES AND NO NEW INFORMED CONSENTS FORMS SHOULD BE ADMINISTERED, OR

    • DID NOT CONSENT TO PROVIDE BIOLOGICAL SAMPLES.

  • IF THE PRE-PREGNANT WOMAN/PREGNANT WOMAN/ADULT CAREGIVER DID NOT CONSENT TO PROVIDE BIOLOGICAL SAMPLES, THIS QUESTIONNAIRE WILL ASK FOR RECONSIDERATION OF BIOLOGICAL SAMPLES.


PROGRAMMER INSTRUCTIONS

  • IF SAMPLE_CONSENT_GIVEN = 1 AND SAMPLE_CONSENT_TYPE = 2, GO TO TIME_STAMP_RQA_ET.

  • IF SAMPLE_CONSENT_GIVEN = 2 AND SAMPLE_CONSENT_TYPE =2, GO TO RECON_BIO_ADULT.


RQA02000/(RECON_BIO_ADULT). We will explain what is involved in the collection of each sample when it is time to collect it.  Will you allow us to collect biological specimens from you? 


DATA COLLECTOR INSTRUCTIONS

  • PRE-PREGNANT WOMEN/PREGNANT WOMEN/ADULT CAREGIVERS WHO AGREE TO ANY SAMPLE COLLECTION SHOULD

    • BE RE-ADMINISTERED CONSENT USING THE INFORMED CONSENT FORM WHAT YOU SHOULD KNOW ABOUT BEING IN THE NATIONAL CHILDREN’S STUDY (NCS) VANGUARD STUDY: INFORMED CONSENT FORM OR THE INFORMED CONSENT FORM WHAT YOU SHOULD KNOW ABOUT BEING IN THE NATIONAL CHILDREN’S STUDY (NCS) VANGUARD STUDY: INFORMED CONSENT FORM FOR PREGNANT WOMAN, AND

    • MAKE THE APPROPRIATE SELECTIONS ON THE SIGNATURE PAGE OF THAT FORM.


Label

Code

Go To

YES

1


NO

2


REFUSED

-1


DON'T KNOW

-2



SOURCE

National Children’s Study, Vanguard 2 Phase


PROGRAMMER INSTRUCTIONS

  • IF EVENT_TYPE = 27 (12-MONTH), 37 (36-MONTH), 40 (48-MONTH), OR 41 (60-MONTH) AND:

    • SAMPLE_CONSENT_GIVEN = 1 AND SAMPLE_CONSENT_TYPE = 1, GO TO PROGRAMMER INSTRUCTIONS AFTER RECON_ENV_DISC.

    • SAMPLE_CONSENT_GIVEN = 2 AND SAMPLE_CONSENT_TYPE = 1 FOR INS_TARGET_PID (ADULT) AND:

      • SAMPLE_CONSENT_GIVEN = 1 AND SAMPLE_CONSENT_TYPE = 1 FOR PERSON_PID_ID (CHILD), GO TO RECON_ENV_DISC.

      • SAMPLE_CONSENT_GIVEN = 2 AND SAMPLE_CONSENT_TYPE = 1 FOR PERSON_PID_ID (CHILD), GO TO PROGRAMMER INSTRUCTIONS AFTER RECON_ENV_DISC.

  • IF EVENT_TYPE = 11 (PRE-PREGNANCY), 15 (PREGNANCY VISIT 2), OR 31 (24-MONTH), GO TO PROGRAMMER INSTRUCTIONS AFTER RECON_ENV_DISC.

RQA03100/(RECON_ENV_DISC). We noticed on your consent form in the past you did not agree to allow us to collect environmental samples, but you agreed to allow us to collect environmental samples on {C_FNAME}'s consent form.  Today, would you like to agree to collection of environmental samples on your consent form as you have agreed to environmental collections for {C_FNAME}? 


Label

Code

Go To

YES

1


NO

2


REFUSED

-1


DON'T KNOW

-2



PROGRAMMER INSTRUCTIONS

  • IF RECON_BIO_ADULT = 1 AND/OR RECON_ENV_DISC ​= 1, GO TO READM_CON.

  • OTHERWISE, GO TO RQA05000.


RQA04000/(READM_CON). Thank you for agreeing to provide samples.  We will now review the consent form to record that you have agreed to provide these samples.


DATA COLLECTOR INSTRUCTIONS

  • RE-ADMINISTER CONSENT USING THE INFORMED CONSENT FORM WHAT YOU SHOULD KNOW ABOUT BEING IN THE NATIONAL CHILDREN’S STUDY (NCS) VANGUARD STUDY: INFORMED CONSENT FORM OR THE INFORMED CONSENT FORM WHAT YOU SHOULD KNOW ABOUT BEING IN THE NATIONAL CHILDREN’S STUDY (NCS) VANGUARD STUDY: INFORMED CONSENT FORM FOR PREGNANT WOMAN AND MAKE THE APPROPRIATE SELECTIONS ON THE SIGNATURE PAGE OF THAT FORM WITH REGARD TO PERMISSION FOR SAMPLE COLLECTIONS.


Label

Code

Go To

CONTINUE

1

TIME_STAMP_RQA_ET

REFUSED

-1

TIME_STAMP_RQA_ET


SOURCE

National Children’s Study, Vanguard 2 Phase


RQA05000. Thank you for your time.  


(TIME_STAMP_RQA_ET).


PROGRAMMER INSTRUCTIONS

  • INSERT DATE/TIME STAMP.


Public reporting burden for this collection of information is estimated to average 1 minute per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0593*). Do not return the completed form to this address.

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